Overview
Reference Number: JO-2103-465604
Senior Regulatory Affairs Associate
Rate: Negotiable
Job Type: Contract
Location: Cambridge
This global biopharmaceutical company is seeking Early Phase Regulatory Affairs Candidates to join them on a contract basis till the end of 2021. The occupier of this position will be responsible for preparing regulatory submissions for Respiratory/Inflammation investigational and commercial products, including the preparation of documentation supporting Clinical Trial Applications (CTAs) and amendments. The crux of the role will involve:
- Preparing CTA documentation
- Attending Clinical Study Management meetings and represent international Regulatory Function at cross functional submission/ study meetings
- Coordinate the submission of clinical, non-clinical and safety regulatory documents in accordance with Regulatory Bodies.
- Post licensing commitments and Market Authorisation
- Ensure licensed product packaging and associated information is maintained in accordance with regulations as well as provide input on labelling
Applicants for this role are expected to:
- Have regulatory submission experience, including support of CTAs within Europe
- Understanding of the EU Centralized procedure and EU regulatory requirements
- Have experience facilitating effective impact and influence strategic planning
- Communicate with excellent verbal and written skills
- Have experience representing Regulatory Affairs with cross-functional teams.
- Experience working with document management systems.
- Life Sciences degree, e.g. Biology, pharmacy or medicine.
